Intermittent Fasting on the Blood Microbiome

ConditionHealthy

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age18-65

SponsorErasmus Medical Center

About this trial

The investigators previously demonstrated that the gut microbiome can be remodeled by one month of intermittent fasting (OMIF) in healthy volunteers and animal models, with a notable alteration observed in its overall composition which could be linked to improvement in liver function. The blood microbiome, which mirrors the human ecosystem and includes all microbes mainly including bacteria, archaea, and viruses, is a new-identified human microbiome assessment tool that is assumed to be more stable and representative than the gut microbiome, with substantial potential for the diagnosis and prediction of liver cirrhosis and cancer. However, the effect of OMIF, which mimics lifestyle change typically advised in liver disease, on this blood microbiome remains elusive at best. The aim of this study is to explore whether OMIF remodels the composition and function of the blood microbiome in healthy volunteers, through a Randomized controlled cross-over trial, with secondary outcomes on the association of blood microbiome with the gut microbiome.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Age 18-65 years

18.5 =< BMI < 25 kg/m2

All genders are included.

Have not fasted (go for a day without any food) for any amount of days in the month before the start of the study

Disqualifiers

Regular use medications such as antibiotics, steroids, beta blockers, and adrenergic-stimulating agents (self-report)

Regular use prebiotic and/or probiotics (self-report)

Intake of antibiotic at least in previous 1 months (self-report)

Daily consumption of >10 cigarettes, or >6 cups of coffee (the latter because of the effects on circadian rhythm). (self-report)

Trial design

Design model

Crossover

Treatments tested in this trial

Intermittent fasting
Dietary supplement
Participants are asked to abstain from any form of fasting or calorie restriction in one month of the study (which is also a pre-fasting washout for those volunteers that might be performing forms of fasting before the study) and then start with one month of intermittent fasting, with daily fasting duration from 7:30 to 18:30. Food is abstained from during fasting, only water and zero-calorie drinks like black coffee and unsweetened tea are allowed.

Treatment groups

48 Participants

are divided into 2 treatment groups

Group A: Intermittent fastingExperimental treatment 1 intervention

Group B: Ad libitum dietsNo intervention 0 interventions

Trial outcomes

Primary outcomes

Change in blood Archaea

Change in blood Archaea after OMIF versus ad libitum diets will be measured with shotgun sequencing technology.

Time frame

One month

Secondary outcomes

Change in blood bacteria

Change in blood bacteria after OMIF versus ad libitum diets will be measured with shotgun sequencing technology.

Time frame

One month

Changes in blood viruses

Changes in blood viruses after OMIF versus ad libitum diets will be measured with shotgun sequencing technology.

Time frame

One month

The relationship between the blood and gut microbiome

The gut microbiome taxa after OMIF versus ad libitum diets will be evaluated using shotgun sequencing technology. The relationship between the blood and gut microbiome will be determined using statistical testing.

Time frame

One month

Other outcomes

Change in BMI

Weight in kilograms and height in meters will be combined to report BMI in kg/m\^2.

Time frame

One month

Change in systolic and diastolic blood pressure

Changes in both systolic and diastolic blood pressure after OMIF versus ad libitum diets will be assessed with a blood pressure monitor.

Time frame

One month

Changes in circulating concentrations of liver enzymes alanine transaminase, aspartate aminotransferase, gamma-glutamyl transferase and alkaline phosphatase

Measured in blood samples \[units/L\]

Time frame

One month

Changes in circulating concentrations of glucose, hemoglobin, fatty acids and cholesterol

Measured in blood samples \[mmol/L\]

Time frame

One month